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临床试验/CTRI/2024/02/062847
CTRI/2024/02/062847尚未招募2 期

Ultrasound guided erector spinae plane block versus wound site infiltration for postoperative analgesia in patients undergoing open nephrectomy

Dayanand Medical college and Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年2月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
To evaluate the analgesic efficacy of ESPB and wound site infiltration in open nephrectomy patients in post operative period.

研究概览

简要总结

Acute pain management in open nephrectomy is a challenging issue, due to large subcostal flank incision that is generally employed to have a wide operative field but, it requires considerable amount of muscle cutting giving rise to somatic pain transmitted through intercostal nerves at T9-T11. In addition, visceral pain is also a component of postoperative pain which is transmitted through sympathetic fibers T8-T12 spinal segments. There are limited studies on erector spinae plane block being used for pain relief in patients undergoing open nephrectomy, hence we propose to study the analgesic efficacy of erector spinae plane block vs wound site infiltration in open nephrectomy surgeries. A randomized observational study will be conducted in ASA I-III patients, aged 18-75 years, of either sex, undergoing open nephrectomy with flank incision under general anesthesia with endotracheal intubation.These patients will be randomly allocated into 2 groups, one group will receive ultrasound guided erector spinae plane block with 30 ml of 0.2% ropivacaine after the induction of general anesthesia and second group will receive  local infiltration of 30 ml of 0.2% ropivacaine (LIA) along the line of skin incision at the end of surgery. Duration of pain relief and  Visual Analogue scale (VAS) scores for pain will be recorded as primary outcome measures, with quality of recovery score (QoR-15) and cumulative amount of rescue analgesia needed, as secondary outcome variables.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of 18-75 years of age, American Society of Anaesthesiologists (ASA) I-III undergoing open nephrectomy with flank incision.

排除标准

  • Patients allergic to local anaesthetics being used
  • Infection at the site of infiltration of local anaesthetic
  • Patients with uncontrolled bleeding diathesis evidenced by history and laboratory investigations
  • Patients with Psychiatric disorder
  • Patients unable to comprehend VAS score
  • Refusal to participate in the study.

结局指标

主要结局

To evaluate the analgesic efficacy of ESPB and wound site infiltration in open nephrectomy patients in post operative period.

时间窗: Comparative consumption of the total amount of rescue opioid analgesic in a 24 hour period among both the groups will be noted and bidirectional Visual Analogue Scale(VAS) will be recorded at rest and on movement preoperatively i.e prior to block administration before induction of general anesthesia and then postoperatively every hourly for the first 4 hours, 2 hourly for next 2 hours and 4 hourly till 24 hours.

次要结局

  • Duration of analgesia and Quality of revovery questionnare(Quality of recovery questionnare at 24 hours postoperatively)

研究者

发起方
Dayanand Medical college and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Udeyana Singh

Dayanand Medical College and Hospital

研究点 (1)

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